FDA-Device2017-05-03Class II
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBS
Arrow International Inc
Hazard
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Sold states
US Distribution to NJ, IL, and PA
Affected count
310 units
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1879-2017Don't want to check this manually?
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